- Among the 51 patients with B-cell lymphoma evaluable for safety, the most common Grade ≥ 3 adverse events were neutropenia (22 percent Grade 3; eight percent Grade 4), which was transient and rarely required dose modification, and Grade ≥ 3 ALT/AST elevations (16 percent Grade 3; two percent Grade 4), the majority of which were managed by dose interruptions and reductions. IPI-145 did not cause a clinically significant effect on hematologic parameters. Six (12 percent of) patients discontinued treatment due to an adverse event.
- The adverse events observed in patients with iNHL were consistent with those reported in patients with B-cell lymphoma.
- There was a 68 percent response rate in patients with iNHL, which included three CRs and 10 PRs among 19 patients evaluable for response. Stable disease was reported in three patients. Additionally, there was a minor response in a patient with Waldenström’s macroglobulinemia.
- Responses were also observed in patients with MCL (one CR and three PRs among six evaluable patients) and HL (one CR among three evaluable patients).
- Responses occurred early, with a median time to response of 1.8 months (range: 1.6 – 4.1 months).
- Among the 34 patients with CLL evaluable for safety, the most common Grade ≥ 3 adverse events were neutropenia (15 percent Grade 3; 12 percent Grade 4), the majority of which did not require dose reduction, and ALT/AST elevations (six percent Grade 3; no Grade 4). The majority of all ALT/AST elevations were managed by dose interruptions and reductions. IPI-145 did not cause a clinically significant effect on hematologic parameters. Seven (21 percent of) patients discontinued treatment due to an adverse event.
- There was a 55 percent response rate in patients with CLL, which included 12 PRs among 22 patients evaluable for response. PRs were defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. 5 Stable disease was reported in nine patients, of which seven had nodal responses.
- The median time to response was 1.9 months (range: 1.8 - 5.6 months).
- Among the 17 patients with T-cell lymphoma, the most common Grade ≥ 3 adverse event was ALT/AST elevation (24 percent), the majority of which were managed by dose interruptions and dose reductions. Clinically significant neutropenia was not observed. Two (12 percent of) patients discontinued treatment due to an adverse event.
- There was a 33 percent response rate in patients with T-cell lymphoma, which included one CR and one PR in patients with peripheral T-cell lymphoma (PTCL) and a PR in a patient with cutaneous T-cell lymphoma (CTCL). Stable disease was reported in two patients with CTCL. The median time to response was 1.9 months (range: 1.7 – 2.7 months).
The data reported at ICML may also be found in the Publications Archive on Infinity’s website http://www.infi.com/product-candidates-publications.asp.About the Phase 1 Trial of IPI-145 in Advanced Hematologic Malignancies The Phase 1, open-label, dose-escalation trial of IPI-145 is designed to evaluate the safety, PK and clinical activity of IPI-145 administered orally BID in patients with advanced hematologic malignancies. The dose-escalation portion of the study is complete, with the maximum tolerated dose defined at 75 mg BID. Infinity is continuing to evaluate IPI-145 in the following seven expansion cohorts:
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